Drug Company Teaming With Yale to Share Trial Data

Johnson & Johnson announced an unusual partnership today with Yale University, in which it will share raw data from many of its clinical trials. The Yale University Open Data Access Project (aptly nicknamed YODA) will “review requests from investigators and physicians seeking access to anonymized clinical trials data from Janssen, the pharmaceutical companies of Johnson & Johnson,” the company wrote in a press release. YODA’s team will then decide which researchers can access the information for their own studies.

The announcement prompted a small explosion ofnewsstories. Forbes wrote that “initially, this will only include products from the drug division, but it will expand to include devices and consumer products.” Janssen’s pharmaceutical products stretch the gamut, including pills for acid reflux, schizophrenia, pain, and birth control, among others. The data to be shared with YODA go well beyond study design and results, and include de-identified information on every volunteer. YODA is led by Harlan Krumholz, a cardiologist who has long pressed for more data access in clinical research. (In 2010, Forbes named him “The Most Powerful Doctor You Never Heard Of.”)

Johnson & Johnson, of course, will get to decide what it sends over to New Haven, although it’s pledging broad disclosure. That’s somewhat in contrast with a controversy brewing in Europe, where drug regulators are hoping to release the same kind of raw data submitted to it by pharmaceutical companies. That effort has been met with pushback and lawsuits. But it is part of a broader shift in both the United States and Europe, where researchers and some regulators are increasingly frustrated by the secrecy surrounding many drug trials, and want to get the information out in the open.